Assoc Prof Christopher Williams

Objectives: To evaluate the ionizing radiation dose received by the eyes of orthopaedic surgeons during various orthopaedic procedures. Secondary objective was to compare the ionizing radiation dose received between differing experience level. Design: Prospective comparative study between January 2013 and May 2014. Setting: Westmead Hospital, a Level 1 Trauma Centre for Greater Western Sydney. Participants: A total of 26 surgeons volunteered to participate within the study. Intervention: Experience level, procedure performed, fluoroscopy time, dose area product, total air kerma, and eye dose received was recorded. Participants were evaluated on procedure and experience level. Main Outcome Measurements: Radiation dose received at eye level by the primary surgeon during an orthopaedic procedure. Results: Data from a total of 131 cases was recorded and included for analysis. The mean radiation dose detected at the eye level of the primary surgeon was 0.02 mSv (SD = 0.05 mSv) per procedure. Radiation at eye level was only detected in 31 of the 131 cases. The highest registered dose for a single procedure was 0.31 mSv. Femoral nails and pelvic fixation procedures had a significantly higher mean dose received than other procedure groups (0.04 mSv (SD = 0.07 mSv) and 0.04 mSv (SD = 0.06 mSv), respectively). Comparing the eye doses received by orthopaedic consultants and trainees, there was no significant difference between the 2 groups. Conclusions: The risk of harmful levels of radiation exposure at eye level to orthopaedic surgeons is low. This risk is greatest during insertion of femoral intramedullary nails and pelvic fixation, and it is recommended that in these situations, surgeons take all reasonable precautions to minimize radiation dose. The orthopaedic trainees in this study were not subjected to higher doses of radiation than their consultant trainers. On the basis of these results, most of the orthopaedic surgeons remain well below the yearly radiation dose of 20 mSv as recommended by the International Commission on Radiological Protection.

Objective: To assess the effectiveness of a multicomponent waitlist optimisation strategy on the proportion of patients overdue to be seen for a neurosurgical (spinal pain) outpatient service at an Australian public hospital. Study design: An interrupted time series study in the outpatient department of a tertiary referral hospital in New South Wales, Australia. Methods: We implemented and evaluated nine waitlist optimisation strategies. We compared a Pre-implementation phase (January 2015¿January 2016), a Implementation phase (February 2016¿December 2017), and a Post-implementation phase (January 2018¿January 2020). We included data from all adults who had been referred for neck and back pain. We used three outcomes of interest; they were: (i) the proportion of patients overdue to be seen (based on their triage category) for a given month, (ii) the proportion of patients that were waiting longer than one year for an initial appointment each month and (iii) the total neurosurgical waitlist number. Results: We included data from 11,520 unique individuals who had a mean age of 54 years (SD 17), 51 % (5900) were female, and 8·8 % (1004) identified as Aboriginal and/or Torres Strait Islander. Across the three phases, there were 26,928 monthly data points Pre-implementation, 36,009 Implementation, and 15,326 Post-implementation. The trend in the proportion of patients overdue to be seen in the Post-Implementation phase was 7 % lower (OR 0·93 [95 % CI 0·89, 0·97]) compared to Pre-implementation. Conclusion: The waitlist optimisation strategies tested in this study led to a large reduction in the proportion of patients overdue to be seen on the neurosurgical waitlist. The tested strategies can be used by other services to address extended waits in outpatient services.

Purpose: Allied health student placements in healthcare settings are complex, constantly evolving, and tailored to real-life environments. The value of student placements in acute and primary healthcare settings is reflected in enhanced student learning, improved service delivery, and positive patient outcomes. This review aims to synthesise the effects of allied health student placements in primary healthcare settings, particularly focusing on older clients' health outcomes and satisfaction with care. Materials and methods: A systematic integrative review was conducted. The five-step integrative review approach, established by Whittemore and Knafl¿was used to allow the inclusion of diverse research methodologies. Five major databases, i.e., Medline-EBSCO, PubMed, PROQUEST, CINAHL, and SCOPUS were searched. The CLUSTER model was used to track additional references. Data were extracted as suggested by Whittemore and Knafl and then thematically synthesised. Results: Eleven papers were reviewed. Despite a lack of rigorous methodologies, five mixed-methods studies, four quantitative studies, one qualitative study, and one cost¿benefit analysis were identified exploring the possible effects of allied health student placements for older clients. From these papers, four main themes were identified: student integration in service delivery, older clients' health outcomes, satisfaction with care, and insights into mechanisms to achieving health and well-being outcomes. Conclusion: This review suggests that integration of allied health students into service delivery can provide additional healthcare support for older clients, but further high-quality research is needed to confirm.

Background: Despite the high prevalence of musculoskeletal (MSK) pain in children, there is a lack of instruments to measure the impact of MSK pain on children's activity and participation. Objective: To assess the reliability and construct validity of the Pediatric MSK Pain Impact summary score in school children (aged 9 to 12) with MSK pain. Methods: We used a pragmatic approach in a reflective framework to assess internal consistency, structural validity, convergent validity, and discriminative validity in a sample of 615 children with MSK pain. Results: The confirmatory factor analysis results indicate that the summary score has limited internal consistency and construct validity. The estimated Cronbach's alpha was 0.63, and most goodness of fit indices met the recommended thresholds (SRMR = 0.030; GFI = 0.993, CFI = 0.955, RMSEA 0.073), although they were close to the lower bounds of the thresholds. The convergent validity showed appropriate correlation of the summary score with quality of life (r = -0.33), care-seeking (r = 0.45), and medication intake (r = 0.37). Discriminative validity showed that the instrument can discriminate between the impact of pain on children with frequent and infrequent (2.93; 95% CI: 2.36 - 3.50) MSK pain. Conclusion: The Pediatric MSK Pain Impact summary showed limited internal consistency and construct validity; however, it can discriminate between children with frequent and infrequent pain. The results are promising for clinical and research practices as it is a short and convenient tool to be used in school-aged children.

Objective: To describe the implementation, feasibility and safety of a day-stay joint replacement pathway in a regional public hospital in Australia. Method: Over a 12-month pilot period, a prospective descriptive analysis of consecutive patients undergoing total knee and hip arthroplasty was conducted. The number of eligible day-stay patients, proportion of successful same-day discharges and reasons for same-day failure to discharge were recorded. Outcome measures captured for all joint replacements across this period included length of stay (LoS), patient reported outcomes, complications and patient satisfaction. The implementation pathway as well as patient and staff identified success factors derived from interviews were outlined. Results: Forty-one/246 (17%) patients booked for joint replacement surgery were eligible for day-stay and 21/41 (51%) achieved a successful same-day discharge. Unsuccessful same-day discharges were due to time of surgery too late in the day (7/20), no longer meeting same-day discharge criteria (11/20) and declined discharge same-day (2/20). Over the implementation period 65% (162/246) of all patients were discharged with a LoS of 2 days or less. Patient satisfaction for the day-stay pathway was high. Complication rates and patient-reported outcomes were equivalent across LoS groups. Conclusion: The day-stay joint replacement surgery pathway was feasible to implement, safe and acceptable to patients. Day-stay pathways have potential patient and system-level efficiency benefits.

Background: International low back pain guidelines recommend providing education/advice to patients, discouraging routine imaging use, and encouraging judicious prescribing of analgesics. However, practice variation occurs and the effectiveness of implementation strategies to promote guideline-concordant care is unclear. This review aims to comprehensively evaluate the effectiveness of implementation strategies to promote guideline-concordant care for low back pain. Methods: Five databases (including MEDLINE, Embase, CINAHL, CENTRAL and PEDro were searched from inception until 22nd August 2024. Randomised controlled trials (RCTs) that evaluated strategies to promote guideline-concordant care (providing education/advice, discouraging routine imaging use, and/or reducing analgesic use) among healthcare professionals or organisations were included. Two reviewers independently conducted screening, data extraction, and risk of bias assessments. The primary outcome was guideline-concordant care in the medium-term (>3 months but <12 months). The taxonomy recommended by the Cochrane Effective Practice and Organisation of Care (EPOC) group was used to categorise implementation strategies. Meta-analysis with a random-effects model was conducted where possible. This systematic review was prospectively registered in PROSPERO (registration number: CRD42023452969). Findings: Twenty-seven RCTs with 32 reports were included. All strategies targeted healthcare professionals (7796 health professionals overseeing 34,890 patients with low back pain), and none targeted organisations. The most commonly used implementation strategies were educational materials (15/27) and educational meetings (14/27), although most studies (24/27) used more than one strategy ('multifaceted strategies'). In the medium-term, compared to no implementation, implementation strategies probably reduced the use of routine imaging (number of studies [N] = 7, odds ratio [OR] = 1.26, 95% confidence interval [CI]: 1.01¿1.58, I2 = 50%, moderate certainty evidence), but made no difference in reducing analgesic use (N = 4, OR = 1.05, 95% CI: 0.96¿1.14, I2 = 0%, high certainty evidence). Further, implementation strategies may make no difference to improve the rate of providing education/advice (N = 3, OR = 1.83, 95% CI: 0.87¿3.87, I2 = 95%, low certainty evidence), but this finding should be interpreted with caution because the sensitivity analysis showed a weak positive finding indicating unstable results that are likely to change with future research (N = 2, OR = 1.18, 95% CI: 1.04¿1.35, I2 = 0%, moderate certainty evidence). No difference was found when comparing one implementation strategy to another in the medium-term. Interpretation: Implementing guideline recommendations delivered mixed effects in promoting guideline-concordant care for low back pain management. Funding: There was no funding source for this review.

t OBJECTIVE: To estimate the difference in confidence to become active despite low back pain in people who were exposed to one of 2 video interventions delivered on social media, compared to no intervention. t DESIGN: A proof-of-concept, 3-group randomized controlled trial, in a 1:1:1 ratio. t METHODS: Participants aged 18 years and over, with and without low back pain, were recruited via the social media channel Facebook, to view either a humorous video, a neutral video, or to no intervention. The videos were delivered online, explained evidence-based management for low back pain, and were designed to "go viral." The primary outcome was confidence in becoming active despite pain, measured using the Pain Self Efficacy Questionnaire (Item 10) (ranges from 0 [not at all confident] to 6 [completely confident]) immediately after watching the video. We aimed to capture the real-time impact and immediate reactions that contributed to the content's reach.

OBJECTIVES: To (1) estimate the economic cost of disabling musculoskeletal pain in children and adolescents from a health care and societal perspective, (2) identify the characteristics of children and adolescents with higher costs, and (3) estimate the economic cost of children's pain to Brazil. t DESIGN: Prospective cohort study. t METHODS: We recruited children and adolescents with disabling musculoskeletal pain from public and private schools. The economic cost associated with disabling musculoskeletal pain was reported by parents each month for 1 year. The cost categories were health care, lost productivity, and patient/family costs. The sum of the categories resulted in the societal costs. Costs were reported using means, standard errors, medians, interquartile ranges, confidence intervals, and sum for each cost category. We compared participant characteristics between groups with low and high costs, and estimated the health and social cost of children's pain to the Brazilian federal budget. t RESULTS: We included 237 children and adolescents with mean age of 11.8 years (standard deviation, 2.9). Total annual health care costs were $29.58 and $103.13 for health insurance/public health care and out-of-pocket, respectively, per child. Total annual societal costs were $177.62 per child. Individuals in low socioeconomic class E (with a monthly income of up to R$403.00) reported that heavy backpack weight, practice of fewer days of sports, and more negative psychosomatic symptoms were associated with higher health care costs. The annual costs to Brazil from the societal perspective was $1 001 329 553. t CONCLUSION: Disabling musculoskeletal pain in children and adolescents in Brazil imposes a serious economic burden of up to $1 billion on the federal budget.

Studies suggest a high economic burden among children and adolescents with musculoskeletal pain. There is no summary in the literature on the overall economic burden of musculoskeletal pain in children and adolescents. The aim of this systematic review of cost-of-illness studies was to synthesize the economic burden of musculoskeletal pain in children and adolescents. We conducted electronic searches on MEDLINE, EMBASE, CINAHL, EconLit, NHSEED, and HTA databases. We included cost-of-illness studies that estimated healthcare, patient/family, lost productivity, and/or societal costs in children and adolescents with musculoskeletal pain. The risk of bias was assessed with the Consolidated Health Economic Evaluation Reporting Standards checklist. All values were adjusted to the same reference year (2021) and converted to American Dollar. We included 45 cost-of-illness studies (n 5 665,623). Twenty-two studies estimated the annual healthcare costs that ranged from $143 to $41,379 per patient. Nine studies estimated the annual patient/family costs that ranged from $287 to $27,972 per patient. Seven studies estimated the annual lost productivity costs that ranged from $124 to $4671 per patient. Nine studies estimated the annual societal costs that ranged from $1095 to $69,351 per patient. Children and adolescents with juvenile idiopathic arthritis and musculoskeletal pain had higher annual incremental healthcare costs than those without these conditions (mean difference: $3800 higher, 95% confidence interval [CI]: 50-7550; mean difference: $740 higher, 95% CI: 470-1,010, respectively). In conclusion, the estimated annual economic burden of children and adolescents with musculoskeletal pain ranged from $124 to $69,351.

This retrospective, descriptive study, conducted in 2024, analysed Virtual Care Survey (2020¿2022) data of patients' self-reported reflections on use and experiences to investigate relationships between demographics, the number of chronic conditions, and virtual care use among older rural patients (=65 years with at least one chronic condition) living in New South Wales, and their satisfaction with virtual care. Associations between categorical variables were assessed using chi-squared tests, and Kruskal¿Wallis tests were used for continuous variables. Qualitative feedback was analysed thematically. The study included 264 patients (median age 74 years; 51.1% women). Most virtual care appointments (65.3%) were for consultations, check-ups, or review of test results. Over one-third (38.3%) of the patients had multimorbidity and were 1.8 times more likely to have five or more virtual care appointments compared to the patients with one chronic condition. The oldest age group (=80 years) preferred telephone over online mediums (Skype or Zoom) (p < 0.05). Patient satisfaction was high (65.8%), with 60.9% finding virtual care comparable to in-person consultations. Technological issues correlated with more negative experiences (p < 0.05). Key themes were enhanced accessibility and convenience, quality and safety of virtual care, and recommendations for equitable access. Despite positive responses, addressing technological complexities is important for optimising virtual care models for older rural Australians with chronic conditions.

OBJECTIVE: To determine the effect of exercise on pain self-efficacy in adults with nonspecific chronic low back pain (NSCLBP). DESIGN: Intervention systematic review with meta-analysis LITERATURE SEARCH: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, Embase, PsycINFO, and CINAHL databases from October 20, 2018, to March 23, 2022. SELECTION CRITERIA: We included randomized controlled trials that compared the effect of exercise on pain self-efficacy to control, in adults with NSCLBP. DATA SYNTHESIS: We conducted a meta-analysis using a random-effects model. We evaluated the risk of bias using the Cochrane risk-of-bias tool (RoB 2) and judged the certainty of evidence using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) framework. RESULTS: Seventeen trials were included, of which eight (n = 1121 participants; 60.6% female; mean age: 49.6 years) were included in the meta-analysis. Exercise increased pain self-efficacy by 3.02 points (95% confidence interval: 1.72, 4.32) on the 60-point Pain Self-Efficacy Questionnaire. The certainty of evidence was moderate; all trials were at high risk of bias. CONCLUSION: There was moderate-certainty evidence that exercise increased pain self-efficacy in adults with NSCLBP. Future research should investigate if this effect is meaningful, whether it increases with more targeted treatments to enhance pain self-efficacy, and the effects on outcomes for adults with NSCLBP.

Introduction: Lifestyle factors are expected to contribute to the persistence and burden of low-back pain (LBP). However, there are no systematic reviews on the (cost-)effectiveness of combined lifestyle interventions for overweight or obese people with LBP. Aim: To assess whether combined lifestyle interventions are (cost-)effective for people with persistent LBP who are overweight or obese, based on a systematic review. Design: Systematic review Method: PubMed, Cochrane, Embase, CINAHL, PsycINFO and the Wiley/Cochrane Library were searched from database inception till January 6th 2023. Two independent reviewers performed study selection, data-extraction and risk of bias scoring using the Cochrane RoB tool 2 and/or the Consensus Health Economic Criteria list. GRADE was used to assess the level of certainty of the evidence. Results: In total 2510 records were screened, and 4 studies on 3 original RCTs with 216 participants were included. Low certainty evidence (1 study) showed that combined lifestyle interventions were not superior to usual care for physical functioning, pain and lifestyle outcomes. Compared to usual care, moderate certainty evidence showed that healthcare (-$292, 95%CI: 872; -33), medication (-$30, 95% CI -65; -4) and absenteeism costs (-$1000, 95%CI: 3573; -210) were lower for the combined lifestyle interventions. Conclusion: There is low certainty evidence from 3 studies with predominantly small sample sizes, short follow-up and low intervention adherence that combined lifestyle interventions are not superior to physical functioning, pain and lifestyle outcomes compared to usual care, but are likely to be cost-effective.

Background: Low-back pain (LBP) is a common condition seen in primary care. A principal aim during a clinical examination is to identify patients with a higher likelihood of underlying serious pathology, such as vertebral fracture, who may require additional investigation and specific treatment. All 'evidence-based' clinical practice guidelines recommend the use of red flags to screen for serious causes of back pain. However, it remains unclear if the diagnostic accuracy of red flags is sufficient to support this recommendation. Objectives: To assess the diagnostic accuracy of red flags obtained in a clinical history or physical examination to screen for vertebral fracture in patients presenting with LBP. Search methods: Electronic databases were searched for primary studies between the earliest date and 7 March 2012. Forward and backward citation searching of eligible studies was also conducted. Selection criteria: Studies were considered if they compared the results of any aspect of the history or test conducted in the physical examination of patients presenting for LBP or examination of the lumbar spine, with a reference standard (diagnostic imaging). The selection criteria were independently applied by two review authors. Data collection and analysis: Three review authors independently conducted 'Risk of bias' assessment and data extraction. Risk of bias was assessed using the 11-item QUADAS tool. Characteristics of studies, patients, index tests and reference standards were extracted. Where available, raw data were used to calculate sensitivity and specificity with 95% confidence intervals (CI). Due to the heterogeneity of studies and tests, statistical pooling was not appropriate and the analysis for the review was descriptive only. Likelihood ratios for each test were calculated and used as an indication of clinical usefulness. Main results: Eight studies set in primary (four), secondary (one) and tertiary care (accident and emergency = three) were included in the review. Overall, the risk of bias of studies was moderate with high risk of selection and verification bias the predominant flaws. Reporting of index and reference tests was poor. The prevalence of vertebral fracture in accident and emergency settings ranged from 6.5% to 11% and in primary care from 0.7% to 4.5%. There were 29 groups of index tests investigated however, only two featured in more than two studies. Descriptive analyses revealed that three red flags in primary care were potentially useful with meaningful positive likelihood ratios (LR+) but mostly imprecise estimates (significant trauma, older age, corticosteroid use; LR+ point estimate ranging 3.42 to 12.85, 3.69 to 9.39, 3.97 to 48.50 respectively). One red flag in tertiary care appeared informative (contusion/abrasion; LR+ 31.09, 95% CI 18.25 to 52.96). The results of combined tests appeared more informative than individual red flags with LR+ estimates generally greater in magnitude and precision. Authors' conclusions: The available evidence does not support the use of many red flags to specifically screen for vertebral fracture in patients presenting for LBP. Based on evidence from single studies, few individual red flags appear informative as most have poor diagnostic accuracy as indicated by imprecise estimates of likelihood ratios. When combinations of red flags were used the performance appeared to improve. From the limited evidence, the findings give rise to a weak recommendation that a combination of a small subset of red flags may be useful to screen for vertebral fracture. It should also be noted that many red flags have high false positive rates; and if acted upon uncritically there would be consequences for the cost of management and outcomes of patients with LBP. Further research should focus on appropriate sets of red flags and adequate reporting of both index and reference tests.

Background: Low back pain is a common presentation across different healthcare settings. Clinicians need to confidently be able to screen and identify people presenting with low back pain with a high suspicion of serious or specific pathology (e.g. vertebral fracture). Patients identified with an increased likelihood of having a serious pathology will likely require additional investigations and specific treatment. Guidelines recommend a thorough history and clinical assessment to screen for serious pathology as a cause of low back pain. However, the diagnostic accuracy of recommended red flags (e.g. older age, trauma, corticosteroid use) remains unclear, particularly those used to screen for vertebral fracture. Objectives: To assess the diagnostic accuracy of red flags used to screen for vertebral fracture in people presenting with low back pain. Where possible, we reported results of red flags separately for different types of vertebral fracture (i.e. acute osteoporotic vertebral compression fracture, vertebral traumatic fracture, vertebral stress fracture, unspecified vertebral fracture). Search methods: We used standard, extensive Cochrane search methods. The latest search date was 26 July 2022. Selection criteria: We considered primary diagnostic studies if they compared results of history taking or physical examination (or both) findings (index test) with a reference standard test (e.g. X-ray, magnetic resonance imaging (MRI), computed tomography (CT), single-photon emission computerised tomography (SPECT)) for the identification of vertebral fracture in people presenting with low back pain. We included index tests that were presented individually or as part of a combination of tests. Data collection and analysis: Two review authors independently extracted data for diagnostic two-by-two tables from the publications or reconstructed them using information from relevant parameters to calculate sensitivity, specificity, and positive (+LR) and negative (-LR) likelihood ratios with 95% confidence intervals (CIs). We extracted aspects of study design, characteristics of the population, index test, reference standard, and type of vertebral fracture. Meta-analysis was not possible due to heterogeneity of studies and index tests, therefore the analysis was descriptive. We calculated sensitivity, specificity, and LRs for each test and used these as an indication of clinical usefulness. Two review authors independently conducted risk of bias and applicability assessment using the QUADAS-2 tool. Main results: This review is an update of a previous Cochrane Review of red flags to screen for vertebral fracture in people with low back pain. We included 14 studies in this review, six based in primary care, five in secondary care, and three in tertiary care. Four studies reported on 'osteoporotic vertebral fractures', two studies reported on 'vertebral compression fracture', one study reported on 'osteoporotic and traumatic vertebral fracture', two studies reported on 'vertebral stress fracture', and five studies reported on 'unspecified vertebral fracture'. Risk of bias was only rated as low in one study for the domains reference standard and flow and timing. The domain patient selection had three studies and the domain index test had six studies rated at low risk of bias. Meta-analysis was not possible due to heterogeneity of the data. Results from single studies suggest only a small number of the red flags investigated may be informative. In the primary healthcare setting, results from single studies suggest 'trauma' demonstrated informative +LRs (range: 1.93 to 12.85) for 'unspecified vertebral fracture' and 'osteoporotic vertebral fracture' (+LR: 6.42, 95% CI 2.94 to 14.02). Results from single studies suggest 'older age' demonstrated informative +LRs for studies in primary care for 'unspecified vertebral fracture' (older age great...

Objectives: Standards of osteopathic training and regulation differ by geographical location, and little is known regarding the evidence base for education within osteopathy. This review is the first to chart and appraise the osteopathic pedagogical literature and presents recommendations for further research and practice. Methods: A scoping review was conducted using the Arksey and O'Malley framework. A search was conducted of EBSCO, OVID (Embase, Medline), CINAHL, Psycinfo, Open Grey, ProQuest and ERIC databases, to identify research related to osteopathic education. Review, selection, data extraction, characterization and Risk of Bias was performed by two independent reviewers and results were summarised using Critical Interpretive Synthesis. Results: The search identified 66 research papers published from 2002 to 2022. The included papers varied in terms of purpose, methodology, and detail of reporting. The returns were grouped into five categories Teaching, Assessment, Clinical education and preparedness for practice, Curriculum and Miscellaneous. The evidence is generally of robust methodological quality, with bias rated as 29 Low, 26 Moderate, and 11 High. However, most of the methodological designs would traditionally be considered low on the hierarchy of evidence, with 19 commentary articles and the only Randomised Controlled Trial being rated High risk of bias. Conclusions: The evidence regarding what is taught is underdeveloped and enhancing consensus regarding benchmarking of osteopathic education and minimum competencies is needed. Active learning was an area highlighted as preferred by learners as was self-directed study. This may also integrate more practical learning aids and electronic or online learning.

A review at our institution and a number of other Australian universities was conducted to identify an optimal institutional-wide approach to Research Data Management (RDM). We found, with a few notable exceptions, a lack of clear policies and processes across institutes and no harmonisation in the approaches taken. We identified limited methods in place to cater for the development of Research Data Management Plans (RDMPs) across different disciplines, project types and no identifiable business intelligence (BI) for auditing or oversight. When interviewed, many researchers were not aware of their institution's RDM policy, whilst others did not understand how it was relevant to their research. It was also discovered that primary materials (PM), which are often directly linked to the effective management of research data, were not well covered. Additionally, it was unclear in understanding who was the data custodian responsible for overall oversight, and there was a lack of clear guidance on the roles and responsibilities of researchers and their supervisors. These findings indicate that institutions are at risk in terms of meeting regulatory requirements and managing data effectively and safely. In this paper, we outline an alternative approach focusing on RDM 'Planning' rather than on RDMPs themselves. We developed simple-to-understand guidance for researchers on the redeveloped RDM policy, which was implemented via an online 'RDM+PM Checklist' tool that guides researchers and students. Moreover, as it is a structured tool, it provides real-time business intelligence that can be used to measure how compliant the organisation is and ideally identify opportunities for continuous improvement.

Objectives: This is a protocol for a Cochrane Review (prognosis). The objectives are as follows:. We aim to describe the overall prognosis (focusing on the pain course) and the negative impact(s) of acute and chronic musculoskeletal, widespread, and neuropathic pain in children (aged six to 12 years) and adolescents (aged 13 to 18 years) by evaluating:. incidence of pain recovery at three and 12 months after reporting acute or chronic pain; change in pain severity at three and 12 months after reporting acute or chronic pain; and negative impact(s) of pain at three and 12 months after reporting chronic pain.

Background: Health education interventions are considered critical for the prevention and management of conditions of public health concern. Although the burden of these conditions is often greatest in socio-economically disadvantaged populations, the effectiveness of interventions that target these groups is unknown. We aimed to identify and synthesize evidence of the effectiveness of health-related educational interventions in adult disadvantaged populations. Methods: We pre-registered the study on Open Science Framework https://osf.io/ek5yg/. We searched Medline, Embase, Emcare, and the Cochrane Register from inception to 5/04/2022 to identify studies evaluating the effectiveness of health-related educational interventions delivered to adults in socio-economically disadvantaged populations. Our primary outcome was health related behaviour and our secondary outcome was a relevant biomarker. Two reviewers screened studies, extracted data and evaluated risk of bias. Our synthesis strategy involved random-effects meta-analyses and vote-counting. Results: We identified 8618 unique records, 96 met our criteria for inclusion ¿ involving more than 57,000 participants from 22 countries. All studies had high or unclear risk of bias. For our primary outcome of behaviour, meta-analyses found a standardised mean effect of education on physical activity of 0.05 (95% confidence interval (CI) = -0.09¿0.19), (5 studies, n = 1330) and on cancer screening of 0.29 (95% CI = 0.05¿0.52), (5 studies, n = 2388). Considerable statistical heterogeneity was present. Sixty-seven of 81 studies with behavioural outcomes had point estimates favouring the intervention (83% (95% CI = 73%-90%), p < 0.001); 21 of 28 studies with biomarker outcomes showed benefit (75% (95%CI = 56%-88%), p = 0.002). When effectiveness was determined based on conclusions in the included studies, 47% of interventions were effective on behavioural outcomes, and 27% on biomarkers. Conclusions: Evidence does not demonstrate consistent, positive impacts of educational interventions on health behaviours or biomarkers in socio-economically disadvantaged populations. Continued investment in targeted approaches, coinciding with development of greater understanding of factors determining successful implementation and evaluation, are important to reduce inequalities in health.

Objective: To describe the context of low back pain (LBP) presentations to emergency departments (EDs) by remoteness areas, hospital delineation level and staffing portfolios. Design: A retrospective observational study using routinely captured ED and admission data over a 5-year period (July 2014¿June 2019). Settings: Thirty seven EDs across a large health district in NSW, Australia, covering major cities, inner regional areas and outer regional areas. Participants: Emergency department (ED) presentations with a principal or secondary diagnosis of LBP based on ICD-10 code (M54.5). Main outcome measures: ED presentation and associated admission measures, including presentation rate, referral source, time in ED, re-presentation rate, admission details and cost to the health system. Results: There were 26¿509 ED presentations for LBP across the 5¿years. Time spent in ED was 206¿min for EDs in major cities, 146¿min for inner regional EDs and 89¿min for outer regional EDs. Re-presentation rates were 6% in major cities, 8.8% in inner regional EDs and 11.8% in outer regional EDs. Admission rates were 20.4%, 15.8% and 18.8%, respectively. Conclusions: This study describes LBP presentations across 37 EDs, highlighting the potential burden these presentations place on hospitals. LBP presentations appear to follow different pathways depending on the ED remoteness area, delineation level and staff portfolio.

Background: Physiotherapists deliver evidence-based guideline recommended treatments only half of the time to patients with musculoskeletal conditions. Physiotherapists' behaviour in clinical practice are influenced by many cognitive, social, and environmental factors including time and financial pressures. Many initiatives aimed at improving physiotherapists' uptake of evidence-based care have failed to appreciate the context involved in clinical decisions and clinical practice. Therefore, we aimed to describe: i) opinions toward evidence; ii) how evidence is accessed; iii) factors influencing evidence access; iv) factors influencing evidence application, for physiotherapists working in regional areas. Methods: We used a mixed-methods study with online survey and focus groups. We included registered physiotherapists in the survey and physiotherapists practising in regional New South Wales in the focus groups. Quantitative and qualitative data were used to inform all research objectives. We used eight domains of the Transtheoretical Domains Framework to design survey questions. We analysed quantitative and qualitative data in parallel, then integrated both sources through by developing a matrix while considering the Transtheoretical Domains Framework domains to generate themes. Results: Fifty-seven physiotherapists participated in the study (survey only n = 41; focus group only n = 8; both survey and focus group n = 8). Participants reported that evidence was important, but they also considered patient expectations, colleagues' treatment choices, and business demands in clinical decision making. Physiotherapists reported they access evidence on average 30 minutes or less per week. Competing demands like business administration tasks are barriers to accessing evidence. Participants reported that patient expectations were a major barrier to applying evidence in practice. Environmental and systemic factors, like funding structures or incentives for evidence-based care, and social factors, like lacking or having a culture of accountability and mentorship, were reported as both barriers and enablers to evidence application. Conclusions: This study provides context to physiotherapists' opinion, access, and application of evidence in clinical practice. Physiotherapists' provision of evidence-based care may be improved by enhancing structural support from workplaces to access and apply evidence and exploring discrepancies between physiotherapists' perceptions of patient expectations and actual patient expectations.

Background: While blood transfusion is an essential cornerstone of hematological care, patients requiring repetitive transfusion remain at persistent risk of alloimmunization due to the diversity of human blood group polymorphisms. Despite the promise, user friendly methods to accurately identify blood types from next-generation sequencing data are currently lacking. To address this unmet need, we have developed RBCeq, a novel genetic blood typing algorithm to accurately identify 36 blood group systems. Methods: RBCeq can predict complex blood groups such as RH, and ABO that require identification of small indels and copy number variants. RBCeq also reports clinically significant, rare, and novel variants with potential clinical relevance that may lead to the identification of novel blood group alleles. Findings: The RBCeq algorithm demonstrated 99·07% concordance when validated on 402 samples which included 29 antigens with serology and 9 antigens with SNP-array validation in 14 blood group systems and 59 antigens validation on manual predicted phenotype from variant call files. We have also developed a user-friendly web server that generates detailed blood typing reports with advanced visualization (https://www.rbceq.org/). Interpretation: RBCeq will assist blood banks and immunohematology laboratories by overcoming existing methodological limitations like scalability, reproducibility, and accuracy when genotyping and phenotyping in multi-ethnic populations. This Amazon Web Services (AWS) cloud based platform has the potential to reduce pre-transfusion testing time and to increase sample processing throughput, ultimately improving quality of patient care. Funding: This work was supported in part by Advance Queensland Research Fellowship, MRFF Genomics Health Futures Mission (76,757), and the Australian Red Cross LifeBlood. The Australian governments fund the Australian Red Cross Lifeblood for the provision of blood, blood products and services to the Australian community.

Objectives: This is a protocol for a Cochrane Review (diagnostic). The objectives are as follows:. The objective of this review is to assess the diagnostic accuracy of red flags used to screen for vertebral fracture in patients presenting with low back pain. Where possible, we will report the results of red flags separately for different types of vertebral fracture as follows. Osteoporotic vertebral compression fracture Vertebral traumatic fracture Vertebral stress fracture. Secondary objectives The secondary objective of this review is to assess the influence of sources of heterogeneity on the diagnostic accuracy of red flag tests, if appropriate. In particular, we will assess the healthcare setting (e.g. primary, emergency, or secondary care) and the different types of vertebral fracture (i.e. osteoporotic vertebral compression fracture, vertebral traumatic fracture, and vertebral stress fracture. We will also assess mean age at different cut-off thresholds (e.g. > 50 years of age versus > 70 years of age) across different studies, as this has previously been shown to influence results.

Objective: To assess the reporting quality of exercise interventions from clinical trials of low back pain (LBP). Study design and setting: We conducted a systematic review to assess the reporting quality of randomised controlled trials (RCTs) that investigated the effectiveness of exercise interventions for patients with LBP. Five online databases and Clinical Trial Registries were searched (October 2018). We included RCTs that reported interventions for LBP, containing at least 50% exercise. The Template for Intervention Description and Replication (TIDieR) and the Consensus on Exercise Reporting Template (CERT) reporting checklists were then used to assess quality of reporting. Results: 582 trials were eligible for inclusion. Due to the large number of eligible studies, 100 studies were randomly selected for data extraction and coding with the TIDieR and CERT checklists. The random sample was representative of the 582 eligible trials. The overall completeness of reporting (median (IQR)) of TIDieR items was 59.2% (45.5%¿72.7%) and CERT was 33.3% (22.2%¿52.6%). Conclusions: We found poor overall reporting with both checklists, which has not improved over time or since the introduction of the checklists. More dedicated work is required to address poor reporting of exercise interventions in clinical trials.

Objectives Mediation analysis is a widely used quantitative method for investigating how interventions and exposures in randomised controlled trials and observational studies have an effect on healthcare outcomes. This study aimed to assess the importance of items that should be considered in a consensus meeting aimed at developing a guideline for reporting mediation analyses. Design International online Delphi study. Participants International experts in the development and application of mediation analysis. Main outcome measures The Delphi panel were asked to rate the importance of a list of items for inclusion in a guideline for reporting mediation analyses. Thresholds for disagreement and consensus on importance for inclusion were specified a priori. We used the Research ANd Development/University of California Los Angeles appropriateness method to quantitatively assess the importance for inclusion and panel agreement. Results Nineteen expert panellists (10 female) from seven countries agreed to participate. All panellists contributed to all three rounds conducted between 10 June 2019 and 6 November 2019. The panel reached consensus on 34 unique reporting items for study design, analytic procedures and effect estimates, with three items rated â optional'. Panellists added one extra item and provided 60 qualitative comments for item refinement and prioritisation. Conclusion This Delphi study used a rigorous consensus process to reach consensus on 34 reporting items for studies that use mediation analysis. These results will inform a consensus meeting that will consolidate a core set of recommended items for reporting mediation analyses.

Importance: Mediation analyses of randomized trials and observational studies can generate evidence about the mechanisms by which interventions and exposures may influence health outcomes. Publications of mediation analyses are increasing, but the quality of their reporting is suboptimal. Objective: To develop international, consensus-based guidance for the reporting of mediation analyses of randomized trials and observational studies (A Guideline for Reporting Mediation Analyses; AGReMA). Design, Setting, and Participants: The AGReMA statement was developed using the Enhancing Quality and Transparency of Health Research (EQUATOR) methodological framework for developing reporting guidelines. The guideline development process included (1) an overview of systematic reviews to assess the need for a reporting guideline; (2) review of systematic reviews of relevant evidence on reporting mediation analyses; (3) conducting a Delphi survey with panel members that included methodologists, statisticians, clinical trialists, epidemiologists, psychologists, applied clinical researchers, clinicians, implementation scientists, evidence synthesis experts, representatives from the EQUATOR Network, and journal editors (n = 19; June-November 2019); (4) having a consensus meeting (n = 15; April 28-29, 2020); and (5) conducting a 4-week external review and pilot test that included methodologists and potential users of AGReMA (n = 21; November 2020). Results: A previously reported overview of 54 systematic reviews of mediation studies demonstrated the need for a reporting guideline. Thirty-three potential reporting items were identified from 3 systematic reviews of mediation studies. Over 3 rounds, the Delphi panelists ranked the importance of these items, provided 60 qualitative comments for item refinement and prioritization, and suggested new items for consideration. All items were reviewed during a 2-day consensus meeting and participants agreed on a 25-item AGReMA statement for studies in which mediation analyses are the primary focus and a 9-item short-form AGReMA statement for studies in which mediation analyses are a secondary focus. These checklists were externally reviewed and pilot tested by 21 expert methodologists and potential users, which led to minor adjustments and consolidation of the checklists. Conclusions and Relevance: The AGReMA statement provides recommendations for reporting primary and secondary mediation analyses of randomized trials and observational studies. Improved reporting of studies that use mediation analyses could facilitate peer review and help produce publications that are complete, accurate, transparent, and reproducible..

AbstractObjective To investigate the efficacy, acceptability, and safety of muscle relaxants for low back pain. Design Systematic review and meta-analysis of randomised controlled trials. Data sources Medline, Embase, CINAHL, CENTRAL, ClinicalTrials.gov, clinicialtrialsregister.eu, and WHO ICTRP from inception to 23 February 2021. Eligibility criteria for study selection Randomised controlled trials of muscle relaxants compared with placebo, usual care, waiting list, or no treatment in adults (=18 years) reporting non-specific low back pain. Data extraction and synthesis Two reviewers independently identified studies, extracted data, and assessed the risk of bias and certainty of the evidence using the Cochrane risk-of-bias tool and Grading of Recommendations, Assessment, Development and Evaluations, respectively. Random effects meta-analytical models through restricted maximum likelihood estimation were used to estimate pooled effects and corresponding 95% confidence intervals. Outcomes included pain intensity (measured on a 0-100 point scale), disability (0-100 point scale), acceptability (discontinuation of the drug for any reason during treatment), and safety (adverse events, serious adverse events, and number of participants who withdrew from the trial because of an adverse event). Results 49 trials were included in the review, of which 31, sampling 6505 participants, were quantitatively analysed. For acute low back pain, very low certainty evidence showed that at two weeks or less non-benzodiazepine antispasmodics were associated with a reduction in pain intensity compared with control (mean difference -7.7, 95% confidence interval-12.1 to-3.3) but not a reduction in disability (-3.3, -7.3 to 0.7). Low and very low certainty evidence showed that non-benzodiazepine antispasmodics might increase the risk of an adverse event (relative risk 1.6, 1.2 to 2.0) and might have little to no effect on acceptability (0.8, 0.6 to 1.1) compared with control for acute low back pain, respectively. The number of trials investigating other muscle relaxants and different durations of low back pain were small and the certainty of evidence was reduced because most trials were at high risk of bias. Conclusions Considerable uncertainty exists about the clinical efficacy and safety of muscle relaxants. Very low and low certainty evidence shows that non-benzodiazepine antispasmodics might provide small but not clinically important reductions in pain intensity at or before two weeks and might increase the risk of an adverse event in acute low back pain, respectively. Large, high quality, placebo controlled trials are urgently needed to resolve uncertainty. Systematic review registration PROSPERO CRD42019126820 and Open Science Framework https://osf.io/mu2f5/.

Background: Social deprivation is broadly defined as the restriction of access an individual has to social or cultural interactions due to poverty, discrimination or other disadvantages. While social deprivation is a widely acknowledged determinant of outcome in musculoskeletal conditions, it remains unclear how this is considered in the conduct and interpretation of musculoskeletal trials. Aim: To determine the frequently to which measures of social deprivation are reported in trials recruiting people with musculoskeletal diseases. Materials and Methods: We conducted a Pubmed search of randomised controlled trials published between 01 January 2019 and 01 June 2020. We included full-text papers of trials recruiting people with musculoskeletal diseases, irrespective of intervention type or origin. We extracted data relating to trial characteristics, setting, trial design, funding source and musculoskeletal disease. We extracted data on any reported social deprivation index or measure of social deprivation based on internationally adopted indicators. We analysed data descriptively to summarise the reporting of each social deprivation index and measure of social deprivation within trials. Results: From 2133 potentially eligible citations, 402 were eligible. Mean age of participants was 51.7 years; 63% were female. Trials most frequently recruited people with spinal pain (24.6%) or osteoarthritis (10.0%). Two trials (0.5%) reported social deprivation indices/scores. When assessed by discrete measures of social deprivation, 164 trials (40.8%) reported one or more social deprivation measures. The most commonly reported measures were morbidity (20.2%), employment status (17.7%) and educational attainment (15.5%). Race (6.7%), ethnicity (6.2%) and annual salary (1.3%) were infrequently reported. One trial (0.3%) presented subgroup results by social deprivation measures. Discussion and Conclusion: Social deprivation is inconsistently reported in musculoskeletal trials. Trialists should report baseline measures of social deprivation in trial reports and aid generalisability to target population, and to examine whether social deprivation might modify treatment effects of interventions for musculoskeletal conditions.

Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows:. To assess the benefits and harms of telerehabilitation for patients with OA of the knee or hip.

Objectives: Pandemics pressure national governments to respond swiftly. Mitigation efforts created an imbalance between population health, capacity of the healthcare system and economic prosperity. Each pandemic arising from a new virus is unknown territory for policy makers, and there is considerable uncertainty of the appropriateness of responses and outcomes. Methods: A qualitative approach was used to review mixed sources of data including Australian reports, official government publications, and COVID-19 data to discern robust future responses. Publicly available epidemiological and economic data were utilised to provide insight into the impact of the pandemic on Australia's healthcare system and economy. Results: Policies implemented by the Australian Government to mitigate the spread of COVID-19 impacted the healthcare sector and economy. This paper incorporates lessons learned to inform optimal economic preparedness. The rationale for an economic response plan concomitant with the health pandemic plan is explored to guide Australian Government policy makers in ensuring holistic and robust solutions for future pandemics. Conclusions: In future, an Australian Economic Pandemic Response Plan will aid in health and economic system preparedness, whilst a strong Australian economy and strategic planning will ensure resilience to future pandemics.

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:. To evaluate the effectiveness of physical activity or education about physical activity, or both, compared to active medical care, waiting list, or usual care in children and adolescents with chronic musculoskeletal pain.

Objective: To determine the magnitude of the association between cardiovascular disease and chronic musculoskeletal pain. Design: Systematic review with meta-Analysis. Methods: A comprehensive search was performed in five electronic databases. Population-based studies reporting the prevalence of cardiovascular diseases in adults stratified by chronic musculoskeletal pain status were considered eligible. Two independent reviewers performed the screening of the records following the inclusion criteria, extracted data, and evaluated the risk of bias of the included studies using an assessment tool of risk of bias for observational studies. In addition, we assessed the overall quality of evidence using an adaptation of the GRADE approach for prognosis. Results: Twenty studies were included in this review. There was high-quality evidence that people with chronic musculoskeletal pain are 1.91 times more likely to report having a cardiovascular disease compared with those without chronic musculoskeletal pain (risk ratio = 1.91, 95% confidence interval = 1.64-2.21). Conclusions: Our findings demonstrated associations between chronic musculoskeletal pain and any cardiovascular diseases. Future studies are still warranted to better understand the association between chronic musculoskeletal pain and the specific types of cardiovascular diseases.

International clinical practice guidelines for low back pain (LBP) contain consistent recommendations including universal provision of information and advice to remain active, discouraging routine referral for imaging, and limited prescription of opioids. This systematic review describes usual care provided by first-contact physicians to patients with LBP. Studies that reported the assessments and care provided to people with LBP in family practice and emergency departments (EDs) from January 2000 to May 2019 were identified by searches of PubMed, EMBASE, and CINAHL. Study quality was assessed with reference to representativeness of samples, potential misclassification of patients, potential misclassification of outcomes, inconsistent data and precision of the estimate, and the findings of high-quality studies were prioritized in the data synthesis. We included 26 studies that reported data from almost 195,000 patients: 18 from family practice, and 8 from EDs. Less than 20% of patients with LBP received evidence-based information and advice from their family practitioner. Around 1 in 4 patients with LBP received referral for imaging in family practice and 1 in 3 in EDs. Up to 30% of patients with LBP were prescribed opioids in family practice and up to 60% in EDs. Large numbers of patients who saw a physician for LBP received care that is inconsistent with evidence-based clinical practice guidelines. Usual care included overuse of imaging and opioid prescription and underuse of advice and information. Suboptimal care may contribute to the massive burden of the condition worldwide.

Objective: To assess the effectiveness of weight-loss interventions on pain and disability in people with knee and hip osteoarthritis (OA) and spinal pain. Design: Intervention systematic review. Literature Search: Twelve online databases and clinical trial registries. Study Selection Criteria: Randomized controlled trials of any weight-loss intervention (eg, diet, physical activity, surgical, pharmaceutical) that reported pain or disability outcomes in people with knee or hip OA or spinal pain. Data Synthesis: We calculated mean differences or standardized mean differences (SMDs) and 95% confidence intervals (CIs). We used the Cochrane risk of bias tool to assess risk of bias and the Grading of Recommendations Assessment, Development, and Evaluation tool to judge credibility of evidence. Results: Twenty-two trials with 3602 participants were included. There was very low- to very low-credibility evidence for a moderate effect of weight-loss interventions on pain intensity (10 trials, n = 1806; SMD, -0.54; 95% CI: -0.86, -0.22; I2 = 87%, P<.001) and a small effect on disability (11 trials, n = 1821; SMD, -0.32; 95% CI: -0.49, -0.14; I2 = 58%, P <.001) compared to minimal care for people with OA. For knee OA, there was low- to moderate-credibility evidence that weight-loss interventions were not more effective than exercise only for pain intensity and disability, respectively (4 trials, n = 673; SMD, -0.13; 95% CI: -0.40, 0.14; I2 = 55%; 5 trials, n = 737; SMD, -0.20; 95% CI: -0.41, 0.00; I2 = 32%). Conclusion: Weight-loss interventions may provide small to moderate improvements in pain and disability for OA compared to minimal care. There was limited and inconclusive evidence for weight-loss interventions targeting spinal pain.

Background and purpose: Human papillomavirus-associated oropharyngeal cancer (HPV+ OPC) with regional lymph node metastases has a good prognosis following (chemo)radiation therapy (C/RT) but lymph nodes may remain detectable for several months. Delayed [18F]-Fluorodeoxyglucose positron emission tomography/computed tomography (PET) can identify patients who may avoid post-treatment neck dissection (PTND). We investigated the rate of PTND in HPV+ OPC treated with C/RT and delayed PET-directed management of the neck. Materials and methods: This is a retrospective cohort study from a prospectively updated institutional database. Eligible patients were treated between January 2005 and July 2017 with a minimum of 18 months follow up, had node-positive, non-distant metastatic HPV+ OPC and were treated with RT (70 Gy/35#/5 per week) with concurrent Cisplatin or Cetuximab, or accelerated RT alone (68 Gy/34#/6 per week). The primary endpoint was rate of PTND. Secondary endpoints were locoregional failure free survival (LRFFS), regional failure free survival (RFFS), distant metastatic failure free survival (DMFFS), overall survival (OS) and oropharyngeal cancer-specific survival (CSS). Results: 418 patients were eligible. Nineteen patients (4.5%) received a PTND. None of the tested variables were associated with an increased risk of PTND. Five-year probabilities for LRFFS, RFFS, DMFS, OS and CSS were, 91.2% (95% CI 88.3¿94.2), 93.4% (95% CI 90.8¿96.0), 91.2% (95% CI 88.3¿94.2), 86.4% (95% CI 83.0¿90.1) and 90.2% (95% CI 87.1¿93.4), respectively. Conclusion: In a large cohort with good median follow up and protocolized C/RT, delayed PET-directed management of the neck affords a lower rate of PTND than reported in historical series without compromising disease control and survival.

Objectives: The objective of this study was to investigate whether systematic reviews of mediation studies identify limitations in reporting quality and methodological conduct. Study Design and Setting: We conducted an overview of systematic reviews. We searched four databases (MEDLINE, PsycINFO, Cochrane Database of Systematic Reviews, and PubMed) to identify systematic reviews of studies that used mediation analysis to investigate mechanisms of health care interventions or exposures in clinical populations between 2007 and 2017. Two reviewers independently screened titles and abstracts. Summary data on the characteristics, reporting quality, and methodological conduct of the studies included in the systematic reviews were extracted independently by two reviewers. The protocol was prospectively registered on PROSPERO (CRD42017059834). Results: Fifty-four systematic reviews were included, representing 11 health care fields, 26 health conditions, and 2008 mediation studies. Eighteen of fifty-four systematic reviews (33%) explicitly stated that the reporting of primary studies was suboptimal. Of these, 14/18 (78%) reviews noted incomplete reporting of effect sizes and precision estimates from mediation analyses. Twenty-nine of fifty-four systematic reviews (54%) identified limitations in the methodological conduct of primary studies. Conclusion: The reporting and methodological conduct of studies investigating mechanisms in health care seems to be suboptimal. Guidance is needed to improve the quality, completeness, and transparency of mediation studies.

Background: Economic evaluations which estimate cost-effectiveness of potential treatments can guide decisions about real-world healthcare services. We performed an economic evaluation of a healthy lifestyle intervention targeting weight loss, physical activity and diet for patients with chronic low back pain, who are overweight or obese. Methods: Eligible patients with chronic low back pain (n¿=¿160) were randomized to an intervention or usual care control group. The intervention included brief advice, a clinical consultation and referral to a 6-month telephone-based healthy lifestyle coaching service. The primary outcome was quality-adjusted life years (QALYs). Secondary outcomes were pain intensity, disability, weight and body mass index. Costs included intervention costs, healthcare utilization costs and work absenteeism costs. An economic analysis was performed from the societal perspective. Results: Mean total costs were lower in the intervention group than the control group (-$614; 95%CI: -3133 to 255). The intervention group had significantly lower healthcare costs (-$292; 95%CI: -872 to -33), medication costs (-$30; 95%CI: -65 to -4) and absenteeism costs (-$1,000; 95%CI: -3573 to -210). For all outcomes, the intervention was on average less expensive and more effective than usual care, and the probability of the intervention being cost-effective compared to usual care was relatively high (i.e., 0.81) at a willingness-to-pay of $0/unit of effect. However, the probability of cost-effectiveness was not as favourable among sensitivity analyses. Conclusions: The healthy lifestyle intervention seems to be cost-effective from the societal perspective. However, variability in the sensitivity analyses indicates caution is needed when interpreting these findings. Significance: This is an economic evaluation of a randomized controlled trial of a healthy lifestyle intervention for chronic low back pain. The findings suggest that a healthy lifestyle intervention may be cost-effective relative to usual care.

Purpose: To assess the causal mechanisms of a healthy lifestyle intervention for patients with chronic low back pain and knee osteoarthritis, who are overweight or obese. Methods: We conducted causal mediation analyses of aggregated data from two randomized controlled trials (RCTs); which included 160 patients with chronic low back pain, and 120 patients with knee osteoarthritis. The intervention consisted of brief advice and referral to a six-month telephone-based healthy lifestyle coaching service. We used causal mediation to estimate the indirect, direct and path-specific effects of hypothesized mediators including: self-reported weight, diet, physical activity, and pain beliefs. Outcomes were pain intensity, disability, and quality of life (QoL). Results: The intervention did not reduce weight, improve diet or physical activity or change pain beliefs, and these mediators were not associated with the outcomes. Sensitivity analyses showed that our estimates were robust to the possible effects of unknown and unmeasured confounding. Conclusions: Our findings show that the intervention did not cause a meaningful change in the hypothesized mediators, and these mediators were not associated with patient-reported outcomes.

Issue addressed: School-based nutrition policies can have a positive effect on the school food environment. The primary aim of this study was to assess the primary school adherence to a mandatory state-wide healthy canteen policy 12¿months after an effective multi-strategic implementation intervention concluded. Methods: Primary schools were randomised to (a) a 12-14¿months multi-strategic intervention or (b) no-intervention (control). The intervention aimed to improve implementation of a state-wide canteen policy by encouraging schools to remove unhealthy food and beverages (classified as ''red'' or ''banned'') from canteen menus and replace with healthy items (classified as ''green''). No implementation support was provided to either group by the research team between the 12 and 24¿months data collection period. Results: Seventy schools participated, of which 56 schools were assessed at 24-month follow-up. Intervention schools were less likely to have a menu which contained ''red/banned'' items at 24-month follow-up (RR¿=¿2.28; 95% CI: 1.18-4.40; P¿=¿0.01). Intervention schools, however, were not more likely than controls to have a menu which contained >50% ''green'' items at 24-month follow-up (RR¿=¿1.29; 95% CI: 0.98-1.70; P¿=¿0.10). Intervention schools were more likely to adhere to both policy components (no red/banned items and >50% green items on the menu) than control schools (RR¿=¿2.61; 95% CI: 1.29-5.29; P¿=¿0.006). Among intervention schools that were fully adherent to the policy following implementation support (12-month post baseline), all were also adherent at the 24-month follow-up. Conclusion: The intervention was effective in achieving long-term school adherence to a state-wide canteen policy at 24-month follow-up. So what?: The findings suggest that sustained improvements in implementation of school nutrition policies is possible following a period (12¿months) of comprehensive implementation support.

Emerging evidence suggests that musculoskeletal (MSK) pain should be viewed froma biopsychosocial perspective and consider the influence of family factors.We conducted a reviewwithmeta-Analysis to provide summary estimates of effect of family history of pain on childhood MSK pain and explore whether specific family pain factors influence the strength of the association (PROSPERO CRD42018090130). Included studies reported associations between family history of pain and nonspecific MSK pain in children (age ,19 years). The outcome of interest was MSK pain in children.We assessed themethodological quality using a modified version of the Quality in Prognosis Studies instrument and quality of evidence for themain analyses using theGRADE criteria. After screening of 7281 titles, 6 longitudinal and 23 cross-sectional studies were included. Moderate quality evidence from 5 longitudinal studies (n 5 42,131) showed that children with a family history of MSK pain had 58%increased odds of experiencing MSK pain themselves (odds ratio [OR] 1.58, 95% confidence interval 1.20-2.09). Moderate quality evidence from 18 cross-sectional studies (n 5 17,274) supported this finding (OR 2.02, 95% 1.69-2.42). Subgroup analyses showed that the relationship was robust regardless ofwhether a child's mother, father, or sibling experienced pain. Odds were higher when both parents reported pain compared with one ([mother OR51.61; father OR51.59]; both parentsOR52.0).Our findings showmoderate quality evidence that childrenwith a family history of pain are at higher risk of experiencing MSK pain. Understanding the mechanism by which this occurs would inform prevention and treatment efforts.

Implementation of interventions in community organisations such as schools, childcare centres, and sporting clubs are recommended to target a range of modifiable risks of non-communicable diseases. Poor implementation, however, is common and has contributed to the failure of non-communicable disease interventions globally. This study aimed to characterise experimental research regarding strategies to improve implementation of chronic disease prevention programs in community settings. The review used data collected in three comprehensive systematic reviews undertaken between August 2015 and July 2017. Randomised controlled trials, including cluster design, and non-randomised trials with a parallel control group were included. The data were extracted to describe trial characteristics, implementation strategies employed, implementation outcomes and study quality. Of the 40 implementation trials included in the study, unhealthy diet was the most common risk factor targeted (n = 20). The most commonly reported implementation strategies were educational meetings (n = 38, 95%), educational materials (n = 36, 90%) and educational outreach visits (n = 29, 73%). Few trials were conducted 'at-scale' (n = 8, 20%) or reported adverse effects (n = 5, 13%). The reporting of implementation related outcomes; intervention adoption (n = 13, 33%); appropriateness (n = 11, 28%); acceptability (n = 8, 20%); feasibility (n = 8, 20%); cost (n = 3, 8%); and sustainability (n = 2, 5%); was limited. For the majority of trials, risk of bias was high for blinding of study personnel/participants and outcome assessors. Testing of strategies to improve implementation of non-communicable disease prevention strategies in community settings, delivered 'at-scale', utilising implementation frameworks, including a comprehensive range of implementation outcomes should be priority areas for future research in implementation science.

Background: Persistent pain is a prevalent condition that negatively influences physical, emotional, social and family functioning in adolescents. Pain science education is a promising therapy for adults, yet to be thoroughly investigated for persistent pain in adolescents. There is a need to develop suitable curricula for adolescent pain science education. Methods: An interdisciplinary meeting of 12 clinicians and researchers was held during March 2018 in Adelaide, South Australia. An a priori objective of the meeting was to identify and gain consensus on key learning objectives for adolescent pain science education using a modified-Delphi process. Results and Conclusion: Consensus was reached via a modified Delphi process for seven learning objectives to form the foundation of a curriculum: 1) Pain is a protector; 2) The pain system can become overprotective; 3) Pain is a brain output; 4) Pain is not an accurate marker of tissue state; 5) There are many potential contributors to anyone's pain; 6) We are all bioplastic and; 7) Pain education is treatment. Recommendations are made for promising areas for future research in adolescent pain science education.

In 2014, the Paracetamol for Acute Low Back Pain (PACE) trial demonstrated that paracetamol had no effect compared with placebo in acute low back pain (LBP). However, noncompliance was a potential limitation of this trial. The aim of this study was to investigate the efficacy of paracetamol in acute LBP among compliers. Using individual participant data from the PACE trial (ACTN12609000966291), complier average causal effect (CACE), intention-to-treat, and per protocol estimates were calculated for pain intensity (primary), disability, global rating of symptom change, and function (all secondary) after 2 weeks of follow-up. Compliance was defined as intake of an average of at least 4 of the prescribed 6 tablets of regular paracetamol per day (2660 mg in total) during the first 2 weeks after enrolment. Exploratory analyses using alternative time points and definitions of compliance were conducted. Mean between-group differences in pain intensity on a 0 to 10 scale using the primary time point and definition of compliance were not clinically relevant (propensity-weighted CACE 0.07 [-0.37 to 0.50] P = 0.76; joint modelling CACE 0.23 [-0.16 to 0.62] P = 0.24; intention-to-treat 0.11 [-0.20 to 0.42] P = 0.49; per protocol 0.29 [-0.07 to 0.65] P = 0.12); results for secondary outcomes and for exploratory analyses were similar. Paracetamol is ineffective for acute LBP even for patients who comply with treatment. This reinforces the notion that management of acute LBP should focus on providing patients advice and reassurance without the addition of paracetamol.

BACKGROUND: During adolescence, prevalence of pain and health risk factors such as smoking, alcohol use and poor mental health all rise sharply. The aim of this study was to describe the relationship between back pain and health risk factors in adolescents. METHODS: Cross-sectional data from the Healthy Schools Healthy Futures study, and the Australian Child Wellbeing Project was used, mean age: 14-15 years. Children were stratified according to back pain frequency. Within each strata, the proportion of children that reported drinking alcohol or smoking or that experienced feelings of anxiety or depression was reported. Test-for-trend analyses assessed whether increasing frequency of pain was associated with health risk factors. RESULTS: Data was collected from ~2500 and 3900 children. Larger proportions of children smoked or drank alcohol within each strata of increasing pain frequency. The trend with anxiety and depression was less clear, although there was a marked difference between the children that reported no pain, and pain more frequently. CONCLUSION: Two large, independent samples show adolescents that experience back pain more frequently are also more likely to smoke, drink alcohol and report feelings of anxiety and depression. Pain appears to be part of the picture of general health risk in adolescents.

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To answer the clinical question: 'what analgesic medicine shall I prescribe this patient with chronic low back pain to reduce their pain?'. The objectives are to determine the analgesic effects, safety, effect on function, and relative rank according to analgesic effect, safety and effect on function of a single course of opioid analgesics, NSAIDs or paracetamol or combinations of these medicines.

Objective: To determine the effectiveness of telephone-based weight loss support in reducing the intensity of knee pain in patients with knee osteoarthritis, who are overweight or obese, compared to usual care. Design: We conducted a parallel randomised controlled trial (RCT), embedded within a cohort multiple RCT of patients on a waiting list for outpatient orthopaedic consultation at a tertiary referral hospital in NSW, Australia. Patients with knee osteoarthritis, classified as overweight or obese [body mass index (BMI) between =27 kg/m2 and <40 kg/m2] were randomly allocated to receive referral to an existing non-disease specific government funded 6-month telephone-based weight management and healthy lifestyle service or usual care. The primary outcome was knee pain intensity measured using an 11-point numerical rating scale (NRS) over 6-month follow-up. A number of secondary outcomes, including self-reported weight were measured. Data analysis was by intention-to-treat according to a pre-published analysis plan. Results: Between May 19 and June 30 2015, 120 patients were randomly assigned to the intervention (59 analysed, one post-randomisation exclusion) or usual care (60 analysed). We found no statistically significant between group differences in pain intensity [area under the curve (AUC), mean difference 5.4, 95%CI: -13.7 to 24.5, P = 0.58] or weight change at 6 months (self-reported; mean difference -0.4, 95%CI: -2.6 to 1.8, P = 0.74). Conclusions: Among patients with knee osteoarthritis who are overweight, telephone-based weight loss support, provided using an existing 6-month weight management and healthy lifestyle service did not reduce knee pain intensity or weight, compared with usual care. Trial registration number: ACTRN12615000490572

Purpose: To report health care costs and the factors associated with such costs in people with acute low back pain receiving guideline-recommended first line care. Methods: This is a secondary analysis of a trial which found no difference in clinical outcomes. Participants with acute low back pain received reassurance and advice, and either paracetamol (taken regularly or as needed) or placebo for up to 4¿weeks and followed up for 12¿weeks. Data on health service utilisation were collected by self-report. A health sector perspective was adopted to report all direct costs incurred (in 2015 AUD, 1 AUD¿=¿0.53 Euro). Costs were reported for the entire study cohort and for each group. Various baseline clinical, demographic, work-related and socioeconomic factors were investigated for their association with increased costs using generalised linear models. Results: The mean cost per participant was AUD167.74 (SD¿=¿427.24) for the entire cohort (n¿=¿1365). Most of these costs were incurred in primary care through visits to a general practitioner or physiotherapist. Compared to the placebo group, there was an increase in cost when paracetamol was taken. Multivariate analysis showed that disability, symptom duration and compensation were associated with costs. Receiving compensation was associated with a twofold increase compared to not receiving compensation. Conclusions: Taking paracetamol as part of first line care for acute low back pain increased the economic burden. Higher disability, longer symptom duration and receiving compensation were independently associated with increased health care costs.

SYNOPSIS: Accurate, reliable, and timely assessment of pain is critical for effective management of musculoskeletal pain conditions. The assessment of pain in infants, children, and adolescents with and without cognitive impairment can be particularly challenging to clinicians for a number of reasons, including factors related to the consultation (eg, heterogeneous patient population, time constraints), the clinician (eg, awareness/knowledge of available pain scales), standardized assessment scales (eg, availability, psychometric properties, and application of each scale), the patient (eg, developmental stage, ability to communicate), and the context in which the interaction took place (eg, familiarity with the setting and physiological and psychological state). As a result, pain is frequently not assessed or measured during the consultation and, in many instances, underestimated and undertreated in this population. The purpose of this article is to provide clinicians with an overview of scales that may be used to measure pain in infants, children, and adolescents. Specifically, the paper reviews the various approaches to measure pain intensity; identifies factors that can influence the pain experience, expression, and assessment in infants, children, and adolescents; provides age-appropriate suggestions for measuring pain intensity in patients with and without cognitive impairment; and identifies ways to assess the impact of pain using multidimensional pain scales.

Background: Most preterm infants born at 29-32 weeks gestation now avoid intubation in early life, and thus lack the usual conduit through which exogenous surfactant is given if needed. Objective: The aim of this work was to examine whether a technique of minimally invasive surfactant therapy used selectively at 29-32 weeks gestation would improve outcomes. Methods: We studied the impact of selective administration of surfactant (poractant alfa 100-200 mg/kg) by thin catheter in infants with respiratory distress syndrome on continuous positive airway pressure (CPAP). The threshold for consideration of treatment was CPAP =7 cm H2O and FiO2 =0.35 prior to 24 h of life. In-hospital outcomes were compared before and after introducing minimally invasive surfactant therapy (epochs 1 and 2, respectively). Results: During epoch 2, of 266 infants commencing CPAP, 51 (19%) reached the treatment threshold. Thirty-seven infants received surfactant via thin catheter, and CPAP failure was avoided in 34 of these (92%). For the overall cohort of infants at 29-32 weeks gestation, after the introduction of minimally invasive surfactant therapy, there were reductions in CPAP failure (epoch 1: 14%, epoch 2: 7.2%) and average days of intubation, with equivalent surfactant use and days of respiratory support (intubation + CPAP). Pneumothorax was substantially reduced (from 8.0 to 2.4%). These findings were mirrored within the subgroups reaching the severity threshold in each epoch. The incidence of bronchopulmonary dysplasia was low in both epochs. Conclusions: Selective use of minimally invasive surfactant therapy at 29-32 weeks gestation permits a primary CPAP strategy to be pursued with a high rate of success, and a low risk of pneumothorax.

Objective To describe the magnitude of patient-reported nonadherence with guideline-recommended care for acute low back pain. Design Secondary analysis of data from participants enrolled in the Paracetamol for Acute Low Back Pain study trial, a randomized controlled trial evaluating the effectiveness of paracetamol for acute low back pain. Setting Primary care, general practitioner. Participants Data from participants with acute low back pain (N=1643). Interventions Guideline-recommended care, including reassurance, simple analgesia, and the advice to stay active and avoid bed rest. Also, advice against additional treatments and referral for imaging. Main Outcome Measures Proportion of nonadherence with guideline-recommended care. Nonadherence was defined as (1) failure to consume the advised paracetamol dose, or (2) receipt of additional health care, tests, or medication during the trial treatment period (4wk). Multivariable logistic regression analysis was performed to determine the factors associated with nonadherence. Results In the first week of treatment, 39.7% of participants were classified as nonadherent. Over the 4-week treatment period, 70.0% were nonadherent, and 57.5% did not complete the advised paracetamol regimen. Higher perceived risk of persistent pain, lower level of disability, and not claiming workers' compensation were associated with nonadherence, with odds ratios ranging from.46 to 1.05. Conclusions Adherence to guideline-recommended care for acute low back pain was poor. Most participants do not complete the advised paracetamol regimen. Higher perceived risk of persistence of complaints, lower baseline disability, and participants not claiming workers' compensation were independently associated with nonadherence.

Background: Marketing communication and brand identity is a fundamental principle of advertising and end-user engagement. Health researchers have begun to apply this principle to trial recruitment in primary care. The aim of this study was to evaluate whether a Teaser Campaign using a series of postcards in advance of a conventional mail-out increases the number of primary care clinics that engage with a clinical trial. Methods: Embedded randomised recruitment trial across primary care clinics (general practitioners and physiotherapists) in the Sydney metropolitan area. Clinics in the Teaser Campaign group received a series of branded promotional postcards in advance of a standard letter inviting them to participate in a clinical trial. Clinics in the Standard Mail group did not receive the postcards. Results: From a total of 744 clinics that were sent an invitation letter, 46 clinics in the Teaser Campaign group and 40 clinics in the Standard Mail group responded (11.6% total response rate). There was no between-group difference in the odds of responding to the invitation letter (odds ratio = 1.18, 95% confidence interval = 0.75-1.85, p = 0.49). For physiotherapy clinics and general practice clinics, the odds ratios were 1.43 (confidence interval = 0.82-2.48, p = 0.21) and 0.77 (confidence interval = 0.34-1.75, p = 0.54), respectively. Conclusion: A Teaser Campaign using a series of branded promotional postcards did not improve clinic engagement for a randomised controlled trial in primary care.

Introduction: Musculoskeletal (MSK) pain in children and adolescents is responsible for substantial personal impacts and societal costs, but it has not been intensively or systematically researched. This means our understanding of these conditions is limited, and healthcare professionals have little empirical evidence to underpin their clinical practice. In this article we summarise the state of the evidence concerning MSK pain in children and adolescents, and offer suggestions for future research. Results: Rates of self-reported MSK pain in adolescents are similar to those in adult populations and they are typically higher in teenage girls than boys. Epidemiological research has identified conditions such as back and neck pain as major causes of disability in adolescents, and in up to a quarter of cases there are impacts on school or physical activities. A range of physical, psychological and social factors have been shown to be associated with MSK pain report, but the strength and direction of these relationships are unclear. There are few validated instruments available to quantify the nature and severity of MSK pain in children, but some show promise. Several national surveys have shown that adolescents with MSK pain commonly seek care and use medications for their condition. Some studies have revealed a link between MSK pain in adolescents and chronic pain in adults. Conclusion: Musculoskeletal pain conditions are often recurrent in nature, occurring throughout the life-course. Attempts to understand these conditions at a time close to their initial onset may offer a better chance of developing effective prevention and treatment strategies.

The aim of this study was to describe the research output and citation rates (academic impact) of public health dissemination and implementation research according to research design and study type. A cross sectional bibliographic study was undertaken in 2013. All original data-based studies and review articles focusing on dissemination and implementation research that had been published in 10 randomly selected public health journals in 2008 were audited. The electronic database 'Scopus' was used to calculate 5-year citation rates for all included publications. Of the 1648 publications examined, 216 were original data-based research or literature reviews focusing on dissemination and implementation research. Of these 72% were classified as descriptive/epidemiological, 26% were intervention and just 1.9% were measurement research. Cross-sectional studies were the most common study design (47%). Reviews, randomized trials, non-randomized trials and decision/cost-effectiveness studies each represented between 6 and 10% of all output. Systematic reviews, randomized controlled trials and cohort studies were the most frequently cited study designs. The study suggests that publications that had the greatest academic impact (highest citation rates) made up only a small proportion of overall public health dissemination and implementation research output.

Bridging the gap between research-based evidence and public health policy and practice is a considerable challenge to public health improvement this century, requiring a rethinking of conventional approaches to health research production and use. Traditionally the process of research translation has been viewed as linear and unidirectional, from epidemiological research to identify health problems and determinants, to efficacy and effectiveness trials and studies of strategies to maximise the implementation and dissemination of evidence-based interventions in practice. A criticism of this approach is the considerable time it takes to achieve translation of health research into practice. Hybrid evaluation designs provide one means of accelerating the research translation process by simultaneously collecting information regarding intervention impacts and implementation and dissemination strategy. However, few health promotion research trials employ such designs and often fail to report information to enable assessment of the feasibility and potential impact of implementation and dissemination strategies. In addition to intervention effects, policy makers and practitioners also want to know the impact of implementation strategies. This commentary will define the three categories of effectiveness-implementation hybrid designs, describe their application in health promotion evaluation, and discuss the potential implications of more systematic use of such designs for the translation of health promotion and evaluation.So what?Greater use of effectiveness-implementation hybrid designs may accelerate research translation by providing more practice- and policy-relevant information to end-users, more quickly.

Objective This review aimed to examine the impact of interventions involving an explicit sleep component on child body mass index (BMI), diet, and physical activity. Methods A systematic search was undertaken in six databases to identify randomized controlled trials examining the impact of interventions with a sleep component on child BMI, dietary intake, and/or physical activity. A random effects meta-analysis was conducted assessing the impact of included interventions on child BMI. Results Of the eight included trials, three enforced a sleep protocol and five targeted sleep as part of multicomponent behavioral interventions either exclusively or together with nutrition and physical activity. Meta-analysis of three studies found that multicomponent behavioral interventions involving a sleep component were not significantly effective in changing child BMI (n = 360,-0.04 kg/m2 [-0.18, 0.11], I2 = 0%); however, only one study included in the meta-analysis successfully changed sleep duration in children. There were some reported improvements to adolescent diet, and only one trial examined the impact on child physical activity, where a significant effect was observed. Conclusions Findings from the included studies suggest that where improvements in child sleep duration were achieved, a positive impact on child BMI, nutrition, and physical activity was also observed.

Purpose: To determine whether emotional distress reported at the initial consultation affects subsequent healthcare use either directly or indirectly via moderating the influence of symptoms. Methods: Longitudinal observational study of 2891 participants consulting primary care for low back pain. Negative binomial regression models were constructed to estimate independent effects of emotional distress on healthcare use.¿Potential confounders were identified using directed acyclic graphs. Results: After the initial consultation, participants had a mean (SD) of one (1.2) visit for back pain over 3¿months, and nine (14) visits for back pain over 12¿months. Higher reports of anxiety during the initial consultation led to increased short-term healthcare use (IRR 1.06, 95¿% CI 1.01¿1.11) and higher reports of depression led to increased long-term healthcare use (IRR 1.04, 95¿% CI 1.02¿1.07). The effect sizes suggest that a patient with a high anxiety score (8/10) would consult 50¿% more frequently over 3¿months, and a person with a high depression score (8/10) would consult 30¿% more frequently over 12¿months, compared to a patient with equivalent pain and disability and no reported anxiety or depression. Conclusions: Emotional distress in the acute stage of low back pain increased subsequent consultation rates. Interventions that target emotional distress during the initial consultation are likely to reduce costly and potentially inappropriate future healthcare use for patients with non-specific low back pain.

This is the protocol for a review and there is no abstract. The objectives are as follows: The primary aim of the review is to examine the effectiveness of strategies aimed at improving the implementation by childcare services of policies, practices or programmes that promote child healthy eating, physical activity and/or obesity prevention. The secondary aims of the review are to: describe the impact of such strategies on childcare service staffknowledge, skills or attitudes; describe the cost or cost-effectiveness of such strategies; describe any adverse effects of such strategies on childcare services, service staffor children; examine the effect of such strategies on child diet, physical activity or weight status.

This is the protocol for a review and there is no abstract. The objectives are as follows: The primary aims of the review are to examine the effectiveness of strategies aiming to improve the implementation of school-based policies, programs or practices that aim to promote healthy or reduce unhealthy behaviours relating to child diet, physical activity, obesity, or tobacco or alcohol use. Secondary objectives of the review are to: examine the effectiveness of implementation strategies on health behavioural (e.g. fruit and vegetable consumption) and anthropometric outcomes (e.g. BMI, weight); describe the impact of such strategies on the knowledge, skills or attitudes of stakeholders involved in implementing health promoting policies, programs or practices; describe the cost or cost effectiveness of such strategies; describe any unintended adverse effects of strategies on schools, school staff or children.

Background: Systematic reviews of high-quality evidence are used to inform policy and practice. To improve community health, the production of such reviews should align with burden of disease. This study aims to assess if the volume of research output from systematic reviews proportionally aligns with burden of disease assessed using percentages of mortality and disability-adjusted life years (DALYs). Methods: A cross-sectional audit of reviews published between January 2012 and August 2013 in the Cochrane Database of Systematic Reviews (CDSR) and Database of Abstracts of Reviews of Effects (DARE) was undertaken. Percentages of mortality and DALYs were obtained from the 2010 Global Burden of Disease study. Standardised residual differences (SRD) based on percentages of mortality and DALYs were calculated, where conditions with SRD of more than or less than three were considered overstudied or understudied, respectively. Results: 1029 reviews from CDSR and 1928 reviews from DARE were examined. There was a significant correlation between percentage DALYs and systematic reviews published in CDSR and DARE databases (CDSR: r=0.68, p=0.001; DARE: r=0.60, p < 0.001). There was no significant correlation between percentage mortality and number of systematic reviews published in either database (CDSR: r=0.34, p=0.14; DARE: r=0.22, p=0.34). Relative to percentage of mortality, mental and behavioural disorders, musculoskeletal conditions and other non-communicable diseases were overstudied. Maternal disorders were overstudied relative to percentages of mortality and DALYs in CDSR. Conclusions: The focus of systematic reviews is moderately correlated with DALYs. A number of conditions may be overstudied relative to percentage of mortality particularly in the context of health and medical reviews.

Objective The purpose of this study was to identify factors that influence recruitment of patients to an observational study of low back pain (LBP). Methods From 1147 primary care (first health contact) clinicians initially contacted, 138 (physiotherapists and chiropractors) agreed to participate in a large observational study of LBP and were the focus of the current study. Data were collected pertaining to clinicians' characteristics, operational factors, and the number of patients recruited. The association of a variety of clinician characteristics and operational factors with recruitment rate was determined using a multivariate negative binomial regression analysis. Results From October 2011 to November 2012, 1585 patients were screened by 138 study clinicians with 951 eligible patients entering the observational study. Clinicians who were members of their professional association had a recruitment rate less than half that of those who were nonmembers (P <.0001). Clinicians who were trained by telephone had a recruitment rate 4.01 times higher than those trained face to face (P <.0001). Similarly, clinicians who referred a larger number of ineligible participants had a slightly higher recruitment rate with an incident rate ratio of 1.04 per ineligible patient (P <.0001). Other clinicians' characteristics and operational factors were not associated with recruitment. Conclusion This study provides evidence that it is feasible to recruit participants from primary care practices to a simple observational study of LBP. Factors identified as influencing recruitment were professional association (negative association), training by telephone, and referring a higher number of ineligible participants.

Introduction: Around 40% of people presenting to primary care with an episode of acute low back pain develop chronic low back pain. In order to reduce the risk of developing chronic low back pain, effective secondary prevention strategies are needed. Early identification of at-risk patients allows clinicians to make informed decisions based on prognostic profile, and researchers to select appropriate participants for secondary prevention trials. The aim of this study is to develop and validate a prognostic screening tool that identifies patients with acute low back pain in primary care who are at risk of developing chronic low back pain. This paper describes the methods and analysis plan for the development and validation of the tool. Methods/analysis: The prognostic screening tool will be developed using methods recommended by the Prognosis Research Strategy (PROGRESS) Group and reported using the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPOD) statement. In the development stage, we will use data from 1248 patients recruited for a prospective cohort study of acute low back pain in primary care. We will construct 3 logistic regression models to predict chronic low back pain according to 3 definitions: any pain, high pain and disability at 3 months. In the validation stage, we will use data from a separate sample of 1643 patients with acute low back pain to assess the performance of each prognostic model. We will produce validation plots showing Nagelkerke R2 and Brier score (overall performance), area under the curve statistic (discrimination) and the calibration slope and intercept (calibration). Ethics and dissemination: Ethical approval from the University of Sydney Ethics Committee was obtained for both of the original studies that we plan to analyse using the methods outlined in this protocol (Henschke et al, ref 11-2002/3/3144; Williams et al, ref 11638).

Introduction Schools represent a valuable setting for interventions to improve children's diets, as they offer structured opportunities for ongoing intervention. Modifications to the school food environment can increase purchasing of healthier foods and improve children's diets. This study examines the availability of healthy food and drinks, implementation of pricing and promotion strategies in Australian primary school canteens, and whether these varied by school characteristics. Methods In 2012 and 2013, canteen managers of primary schools in the Hunter New England region of New South Wales reported via telephone interview the pricing and promotion strategies implemented in their canteens to encourage healthier food and drink purchases. A standardized audit of canteen menus was performed to assess the availability of healthy options. Data were analyzed in 2014. Results Overall, 203 (79%) canteen managers completed the telephone interview and 170 provided menus. Twenty-nine percent of schools had menus that primarily consisted of healthier food and drinks, and 11% did not sell unhealthy foods. Less than half reported including only healthy foods in meal deals (25%), labeling menus (43%), and having a comprehensive canteen policy (22%). A significantly larger proportion of schools in high socioeconomic areas (OR=3.0) and large schools (OR=4.4) had primarily healthy options on their menus. School size and being a Government school were significantly associated with implementation of some pricing and promotion strategies. Conclusions There is a need to monitor canteen environments to inform policy development and research. Future implementation research to improve the food environments of disadvantaged schools in particular is warranted.

Introduction: A number of jurisdictions internationally have policies requiring schools to implement healthy canteens. However, many schools have not implemented such policies. One reason for this isthat current support interventions cannot feasibly be delivered to large numbers of schools. A promising solution to support population-wide implementation of healthy canteen practices is audit and feedback. The effectiveness of this strategy has, however, not previously been assessed in school canteens. This study aims to assess the effectiveness and cost-effectiveness of an audit and feedback intervention, delivered by telephone and email, in increasing the number of school canteens that have menus complying with a government healthy-canteen policy. Methods and analysis: Seventy-two schools, across the Hunter New England Local Health District in New South Wales Australia, will be randomised to receive the multicomponent audit and feedback implementation intervention or usual support. The intervention will consist of between two and four canteen menu audits over 12 months. Each menu audit will be followed by two modes of feedback: a written feedback report and a verbal feedback/support via telephone. Primary outcomes, assessed by dieticians blind to group status and as recommended by the Fresh Tastes @ School policy, are: (1) the proportion of schools with a canteen menu containing foods or beverages restricted for sale, and; (2) the proportion of schools that have a menu which contains more than 50% of foods classified as healthy canteen items. Secondary outcomes are: the proportion of menu items in each category ('red', 'amber' and 'green'), canteen profitability and cost-effectiveness. Ethics and dissemination: Ethical approval has been obtained by from the Hunter New England Human Research Ethics Committee and the University of Newcastle Human Research Ethics Committee. The findings will be disseminated in usual forums, including peer-reviewed publication and conference presentations.

Background: Overweight and obesity is a significant public health problem that impacts a large number of children globally. Supporting childcare centers to deliver healthy eating and physical activity-promoting policies and practices is a recommended strategy for obesity prevention, given that such services provide access to a substantial proportion of children during a key developmental period. Electronic Web-based interventions represent a novel way to support childcare service providers to implement such policies and practices. Objective: This study aimed to assess: (1) childcare centers' current use of technology, (2) factors associated with intention to use electronic Web-based interventions, and (3) Web-based features that managers rated as useful to support staff with implementing healthy eating and physical activity-promoting policies and practices. Methods: A computer-Assisted telephone interview (CATI) was conducted with service managers from long day care centers and preschools. The CATI assessed the following: (1) childcare center characteristics, (2) childcare centers' use of electronic devices, (3) intention to use a hypothetical electronic Web-based program-Assessed using the Technology Acceptance Model (TAM) with ratings between 1 (strongly disagree) and 7 (strongly agree), and (4) features rated as useful to include in a Web-based program. Results: Overall, 214 service centers out of 277 (77.3%) consented to participate. All service centers except 2 reported using computers (212/214, 99.1%), whereas 40.2% (86/214) used portable tablets. A total of 71.9% (151/210) of childcare service managers reported a score of 6 or more for intention to use a hypothetical electronic Web-based program. In a multivariable logistic regression analysis, intention to use the program was significantly associated with perceived ease of use (P=.002, odds ratio [OR] 3.9, 95% CI 1.6-9.2) and perceived usefulness (P<.001, OR 28,95% CI 8.0-95.2). Features reported by service managers as useful or very useful for a Web-based program included decision-support tools to support staff with menu planning (117/129, 90.7%), links to relevant resources (212/212, 100%), updated information on guidelines (208/212, 98.1%), and feedback regarding childcare center performance in relation to other childcare centers (212/212, 100%). Conclusions: Childcare service managers reported high intention to use a Web-based program and identified several useful features to support staff to implement healthy eating and physical activity policies and practices. Further descriptive and intervention research examining the development and use of such a program to support childcare centers with the implementation of healthy eating and physical activity-promoting policies and practices is warranted.

Background Clinical prediction rules can assist clinicians to identify patients with low back pain (LBP) who are likely to recover quickly with minimal treatment; however, there is a paucity of validated instruments to assist with this task. Method We performed a pre-planned external validation study to assess the generalizability of a simple 3-item clinical prediction rule developed to estimate the probability of recovery from acute LBP at certain time points. The accuracy of the rule (calibration and discrimination) was determined in a sample of 956 participants enrolled in a randomized controlled trial. Results The calibration of the rule was reasonable in the new sample with predictions of recovery typically within 5-10% of observed recovery. Discriminative performance of the rule was poor to moderate and similar to that found in the development sample. Conclusions The results suggest that the rule can be used to provide accurate information about expected recovery from acute LBP, within the first few weeks of patients presenting to primary care. Impact analysis to determine if the rule influences clinical behaviours and patient outcomes is required. © 2014 European Pain Federation - EFIC®.

Background: Regular paracetamol is the recommended first-line analgesic for acute low-back pain; however, no high-quality evidence supports this recommendation. We aimed to assess the efficacy of paracetamol taken regularly or as-needed to improve time to recovery from pain, compared with placebo, in patients with low-back pain. Methods: We did a multicentre, double-dummy, randomised, placebo controlled trial across 235 primary care centres in Sydney, Australia, from Nov 11, 2009, to March 5, 2013. We randomly allocated patients with acute low-back pain in a 1:1:1 ratio to receive up to 4 weeks of regular doses of paracetamol (three times per day; equivalent to 3990 mg paracetamol per day), as-needed doses of paracetamol (taken when needed for pain relief; maximum 4000 mg paracetamol per day), or placebo. Randomisation was done according to a centralised randomisation schedule prepared by a researcher who was not involved in patient recruitment or data collection. Patients and staffat all sites were masked to treatment allocation. All participants received best-evidence advice and were followed up for 3 months. The primary outcome was time until recovery from low-back pain, with recovery defined as a pain score of 0 or 1 (on a 0-10 pain scale) sustained for 7 consecutive days. All data were analysed by intention to treat. This study is registered with the Australian and New Zealand Clinical Trial Registry, number ACTN 12609000966291. Findings:550 participants were assigned to the regular group (550 analysed), 549 were assigned to the as-needed group (546 analysed), and 553 were assigned to the placebo group (547 analysed). Median time to recovery was 17 days (95% CI 14-19) in the regular group, 17 days (15-20) in the as-needed group, and 16 days (14-20) in the placebo group (regular vs placebo hazard ratio 0.99, 95% CI 0.87-1.14; as-needed vs placebo 1.05, 0.92-1.19; regular vs as-needed 1.05, 0.92-1.20). We recorded no difference between treatment groups for time to recovery (adjusted p=0.79). Adherence to regular tablets (median tablets consumed per participant per day of maximum 6; 4.0 [IQR 1.6-5.7] in the regular group, 3.9 [1.5-5.6] in the as-needed group, and 4.0 [1.5-5.7] in the placebo group), and number of participants reporting adverse events (99 [18.5%] in the regular group, 99 [18.7%] in the asneeded group, and 98 [18.5%] in the placebo group) were similar between groups. Interpretation: Our findings suggest that regular or as-needed dosing with paracetamol does not affect recovery time compared with placebo in low-back pain, and question the universal endorsement of paracetamol in this patient group. Funding: National Health and Medical Research Council of Australia and GlaxoSmithKline Australia.

Objective Recent research suggests that sleep quality and pain intensity are intimately linked. Although sleep problems are common in patients with low back pain, the effect of sleep quality on the levels of pain intensity is currently unknown. The aim of this study was to investigate the effect of sleep quality on subsequent pain intensity in patients with recent-onset low back pain. Methods Data on 1,246 patients with acute low back pain were included in the analysis. Sleep quality was assessed using the sleep quality item of the Pittsburgh Sleep Quality Index, scored on a 0-3-point scale, where 0 = very good sleep quality and 3 = very bad sleep quality. Pain intensity was assessed on a numerical rating scale (range 0-10). A generalized estimating equation (GEE) analysis modeled with an exchangeable correlation structure was used to examine the relationship between sleep quality and pain intensity. The model further controlled for symptoms of depression and prognostic factors for low back pain. Results The GEE analysis demonstrated a large effect of poor sleep on subsequent pain intensity, such that for every 1-point decrease in sleep quality (based on a 0-3-point scale), pain intensity (based on a 0-10-point scale) increased by 2.08 points (95% confidence interval 1.99-2.16). This effect was independent of depression and common prognostic factors for low back pain. Conclusion Sleep quality is strongly related to subsequent pain intensity in patients with acute low back pain. Future research is needed to determine whether targeting sleep improvement contributes to pain reduction. Copyright © 2014 by the American College of Rheumatology.

Objectives Expenditure on research has grown substantially; however, a major challenge for conducting successful clinical research is the efficient recruitment of participants. We investigated factors influencing the rate at which general practitioners (GPs) recruit participants to a randomized controlled trial. Study Design and Setting We used data on 363 GPs recruiting participants for a randomized controlled trial of low back pain. Multivariate negative binomial regression was used to determine associations of characteristics of the GP and study operational aspects with the recruitment rate. Results GPs recruited 1,195 participants at a rate of 0.013 participants/day. GPs located in a high socioeconomic area recruited at half the rate as those located in a low socioeconomic area [incident rate ratio (IRR), 0.52; 95% confidence interval (CI): 0.37, 0.74]. A follow-up within 2 weeks of training the GP and a higher number of face-to-face visits were operational procedures associated with a higher rate of recruitment (IRR, 2.15; 95% CI: 1.58, 2.94 and IRR, 1.17; 95% CI: 1.11, 1.24, respectively). Other contacts made with a GP were not associated with recruitment. Conclusion The results suggested that the type of operational procedures used in clinical trial recruitment strategies are important aspects to consider. The ability to predict which GPs will recruit based on GP characteristics seems limited. © 2014 Elsevier Inc. All rights reserved.